Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01188954

Doxycycline Versus Standard Care to Prevent Seroma Formation

Randomized Clinical Trial of Doxycycline Versus Standard Care to Prevent Seroma Formation at Femoral Artery/Vein Cannulation Site After Cardiopulmonary By-Pass

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Northwell Health · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

A seroma is a collection of fluid other than pus or blood which forms through the division of numerous lymphatic channels, which normally drain the interstitial space under the skin. These channels become disrupted during surgical procedure and lead to seroma formation. This collection of fluid causes pressure in the local area, patient discomfort, and provides unfortunately an excellent culture medium for bacteria. Seroma development has been previously described in femoral vessel groin cannulation dissections after surgery. Conventional therapy is limited to draining the fluid, sometimes more than once, until there is full resolution of the seroma. If fluid collection recurs at the surgical site, sclerosant therapy with agents such as doxycycline. Doxycycline has been found to be a cost effective agent used as a sclerosant, which belongs to tetracycline class of antibiotics. The investigators hypothesize that prophylactic use of doxycycline at the site of femoral cannulation will prevent or minimize the area of seroma formation as compared to standard care of patients. The aim is driven towards limiting patient discomfort and visits to the clinic and to improve clinical care.

Conditions

Interventions

TypeNameDescription
DRUGdoxycycline50 ml/mg
OTHERNo interventionNormal Saline/Water

Timeline

Start date
2010-01-01
Primary completion
2012-11-01
Completion
2012-11-01
First posted
2010-08-26
Last updated
2015-04-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01188954. Inclusion in this directory is not an endorsement.